# K230550: JAWS Nitinol Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: May 11, 2023 after 72 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001354 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223056: JAWS Nitinol Staple System, Paragon 28, Inc. (2023) Summary page 4.

## Most influential descendants
- K261121: Megalodon Dynamic Compression System (2026), 0 descendants of its own

## Indications for use
The JAWS® Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis, and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

Source page: https://510kreport.com/device/K230550
Methodology: https://510kreport.com/methodology